Integrated introducer and transmitter assembly and methods of use

ABSTRACT

Method and apparatus for inserting at least a portion of a sensor into a patient is provided.

RELATED APPLICATIONS

The present application is a continuation of U.S. patent applicationSer. No. 13/970,397, filed Aug. 19, 2013, which is a continuation ofU.S. patent application Ser. No. 11/240,259, filed Sep. 30, 2005, nowU.S. Pat. No. 8,512,243, the disclosures of both of which areincorporated herein by reference in their entireties for all purposes.

BACKGROUND OF THE INVENTION

Continuous glucose monitoring systems generally include a sensor such asa subcutaneous analyte sensor, at least a portion of which is insertedunder the skin for fluid contact with interstitial fluid, for detectinganalyte levels such as glucose levels, a transmitter (such as an RFtransmitter) in communication with the sensor and configured to receivethe sensor signals and to transmit them to a corresponding receiver unitby for example, using RF data transmission protocol. The receiver may beoperatively coupled to a glucose monitor that performs glucose relatedcalculations and data analysis.

The transmitter is in signal communication with the sensor. Generally,the sensor is configured to detect and measure the glucose levels of thepatient over a predetermined period of time, and the transmitter isconfigured to transmit data corresponding to or associated with themeasured glucose levels over the predetermined period of time forfurther analysis. To initially deploy the sensor so that the sensorcontacts and electrodes are in fluid contact with the patient'sinterstitial fluids, a separate deployment mechanism such as a sensorinserter or introducer is used. More specifically, the introducerincludes a sharp needle shaped inserter that is configured to piercethrough the skin of the patient and substantially concurrently guide thesensor through the patient's skin so as to place at least a portion ofthe sensor in fluid contact with the target biological fluid of thepatient.

The sharp inserter is typically used only during the sensor insertionprocess, and once the sensor is properly and accurately positioned, theinserter and the introducer are discarded. This requires a level of careas the inserter is sharp and may damage other parts of the patient'sskin if not properly discarded. Further, since the tip of the inserterhas come into fluid contact with the patient's biological fluids, it isimportant to take particular precautions in the handling of the sharpinserter.

Further, to minimize data errors in the continuous or semi-continuousmonitoring system, it is important to properly insert the sensor throughthe patient's skin and securely retain the sensor during the time thatthe sensor is configured to detect analyte levels. In addition toaccurate positioning of the sensor through the skin of the patient, itis important to minimize the level of pain associated with the insertionof the sensor through the patient's skin. Additionally, for the periodof continuous or semi-continuous monitoring which can include, forexample, 3 days, 5 days or 7 days, it is important to have thetransmitter in proper contact with the analyte sensor so as to minimizethe potential errors in the monitored data.

In view of the foregoing, it would be desirable to have method andapparatus which provides for simple handling of the sensor introducerduring sensor deployment and also after the sensor deployment. Morespecifically, it would be desirable to have method and apparatus thatminimizes the potential physical contact with the inserter mechanism andthe patient to minimize the potential for disseminating the biologicalfluids that have come into contact with the inserter, and also, thatprovides for an easy to use sensor insertion mechanism that minimizesthe pain to the patient.

SUMMARY

In one embodiment, there is provided a method and apparatus forproviding an integrated sensor introducer mechanism and transmitter unitfor use in continuous or semi-continuous monitoring systems such asglucose monitoring systems which includes a disposable sensor introducerprovided within the integrated sensor/transmitter assembly and which isretained within the assembly during the time period of the sensor inactive mode.

More specifically, in one embodiment of the present invention, there isprovided an integrated sensor introducer mechanism which may betriggered by a single depression or activation of a switch to deploy thesharp sensor introducer through the skin of the patient. The singledepression trigger mechanism is configured to return to its originalposition upon firing the sensor and the introducer, so that the sharpsensor introducer is removed from the patient after placing the sensorin the patient.

In this manner, the patient is not required to handle the cumbersome andpotentially dangerous and sharp sensor introducer microneedle, forexample. In this manner, a convenient, simple and sanitary sensorinsertion and analyte monitoring system is provided.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A illustrates a perspective view of the overall assembly includingintegrated introducer and transmitter coupled to the transmitter mountwith the switch cover in a closed position in accordance with oneembodiment of the present invention;

FIG. 1B illustrates a perspective view of the overall assembly includingintegrated introducer and transmitter coupled to the transmitter mountwith the switch cover in an open position in accordance with oneembodiment of the present invention;

FIG. 2 illustrates a perspective view of the overall assembly includingintegrated introducer and transmitter coupled to the transmitter mountwith the switch cover in a closed position provided on an adhesive patchin accordance with one embodiment of the present invention;

FIGS. 3A and 3B illustrate the open and closed positions, respectively,of the transmitter unit opening portion on the transmitter unit housingin accordance with one embodiment of the present invention;

FIG. 4 illustrates a close up perspective view of the switch opening inthe open position exposing the sensor introducer trigger mechanism andmounted on the transmitter unit base portion in accordance with oneembodiment of the present invention;

FIGS. 5A-5B illustrate a side view and a perspective view, respectively,of the sensor introducer trigger mechanism with the sensor positioned inthe pre-deployment position in accordance with one embodiment of thepresent invention;

FIG. 6 illustrates a perspective view of the sensor introducer triggermechanism and the transmitter unit base portion in cooperation with thesensor in pre-deployment position in accordance with one embodiment ofthe present invention;

FIG. 7A illustrates a perspective view of the sensor introducer triggermechanism and the transmitter unit base portion in post deploymentposition in accordance with one embodiment of the present invention;

FIG. 7B illustrates a side view of the sensor introducer triggermechanism in post sensor deployment position in accordance with oneembodiment of the present invention;

FIG. 8A is a cross sectional view of the sensor introducer triggermechanism before the sensor insertion in accordance with one embodimentof the present invention;

FIG. 8B is a cross sectional side view of the sensor introducer triggermechanism before the sensor insertion in accordance with one embodimentof the present invention; and

FIGS. 9A and 9B are cross sectional views of the sensor introducertrigger mechanism after sensor insertion and withdrawal of theintroducer for retention within the integrated sensor introducer andtransmitter assembly in accordance with one embodiment of the presentinvention.

DETAILED DESCRIPTION

FIG. 1A illustrates a perspective view of the overall assembly includingintegrated introducer and transmitter coupled to the transmitter mountwith the switch cover in a closed position in accordance with oneembodiment of the present invention, and FIG. 1B illustrates aperspective view of the overall assembly including integrated introducerand transmitter coupled to the transmitter mount with the switch coverin an open position in accordance with one embodiment of the presentinvention. Referring to FIGS. 1A-1B, integrated sensor introducer andtransmitter assembly 100 in one embodiment of the present inventionincludes a transmitter unit 101, a transmitter unit opening portion 102,and transmitter mount base portion 103. As shown, the transmitter unit101 is configured to physically couple to the transmitter mount baseportion 103 so as to provide an integrated assembly. The transmittermount base portion 103 is configured to be placed on the skin of apatient, and as will be discussed in further detail, and includes asensor introducer and the sensor pre-assembled therein.

Referring to FIGS. 1A-1B, the transmitter unit opening portion 102 isconfigured in one embodiment to be slidably displaced between an openposition and a closed position, along the directional arrow 105. As canbe seen, when the transmitter unit opening portion 102 is in the openposition, a sensor introducer trigger mechanism 104 is exposed to thepatient. More specifically, the patient is able to slidably move thetransmitter unit opening portion 102 between the open position and theclosed position to operate the sensor introducer trigger mechanism 104,and upon successfully deploying the sensor transcutaneously to thedesired position, the patient may place the transmitter unit openingportion 102 in the closed position so as to provide cover and protectionto the sensor introducer trigger mechanism 104, and also, to avoidpotential inadvertent interaction with the sensor introducer triggermechanism 104. Within the scope of the present invention, the sensorintroducer trigger mechanism 104 may include a plug or stopper with alatch mechanism.

Referring back to FIGS. 1A-1B, while the transmitter unit openingportion 102 is shown with a slidable movement so as to be displacedbetween the open position and the closed position, within the scope ofthe present invention, the transmitter unit opening portion 102 mayinclude other types of mechanisms to open and close the area exposingthe sensor introducer trigger mechanism 104. For example, thetransmitter unit opening portion 102 may include a hinge portionpivotally mounted to the transmitter unit 101 so that the transmitterunit opening portion 102 may pivotally move to expose and to close thesensor introducer trigger mechanism.

Additionally, a latch mechanism may also be provided so as to securelyplace the transmitter unit opening portion 102 in a closed and latchedposition so as to avoid potential inadvertent exposure of the sensorintroducer trigger mechanism 104. Within the scope of the presentinvention, the latch mechanism may include a Velcro type fastener, abutton type latching mechanism, a tongue and groove type latchmechanism, a snap, a detente, a hook, or any other type of latchingmechanism that would securely place the transmitter unit opening portion102 in the closed position in the event of inadvertent application ofpressure thereto.

FIG. 2 illustrates a perspective view of the overall assembly includingintegrated introducer and transmitter coupled to the transmitter mountwith the switch cover in a closed position provided on an adhesive patchin accordance with one embodiment of the present invention. Referring toFIG. 2, there is shown an adhesive patch 201 that is configured toreceive the transmitter unit base portion 103 on its upper surface,while the lower surface is provided with an adhesive material, and wherethe lower surface is configured to be securely attached to the skin ofthe patient, thus effectively providing a firm and secure mounting ofthe integrated sensor introducer and transmitter assembly 100. As shown,the adhesive patch 201 in one embodiment of the present invention issubstantially flexible and configured to substantially follow thecontour of the patient's skin where the integrated sensor introducer andtransmitter assembly 100 is to be placed for the predetermined period oftime that the patient will be wearing the assembly 100 (for example, 3days, 5 days, 7 days and so on). In this manner, comfort can be providedto the patient while not substantially hindering the patient's dailyactivities.

FIGS. 3A and 3B illustrate the open and closed positions, respectively,of the transmitter unit opening portion on the transmitter unit housing,and FIG. 4 illustrates a close-up, perspective view of the switchopening in the open position exposing the sensor introducer triggermechanism and mounted on the transmitter unit base portion in accordancewith one embodiment of the present invention. Referring to FIGS. 3A-3Band 4, it can be seen that the sensor introducer trigger mechanism 104is positioned substantially within the housing of the integrated sensorintroducer and transmitter assembly 100, shown in one embodiment asincluding the transmitter unit 101 coupled with the transmitter unitbase portion 102.

Moreover, while the transmitter unit 101 is provided with asubstantially circular opening corresponding to the position of thesensor introducer trigger mechanism 104, within the scope of the presentinvention, any suitable shape may be integrated to the housing of thetransmitter unit 101 so as to effectively be opened and closed torespectively expose and seal off the sensor introducer trigger mechanism104 as desired by the patient. For example, the circular opening on thetransmitter unit 101 may alternatively be formed in an oblong shape, atriangular shape, a rectangular shape, and so on.

FIGS. 5A-5B illustrate a side view and a perspective view, respectively,of the sensor introducer trigger mechanism with the sensor positioned inthe pre-deployment position in accordance with one embodiment of thepresent invention. Referring to FIGS. 5A and 5B, as can be seen, thesensor introducer trigger mechanism 104 in one embodiment includes atrigger portion 501 operatively coupled to an introducer portion 502. Asshown, the trigger portion 501 of the sensor introducer triggermechanism 104 is configured to displace the introducer portion 502 in asubstantially skin-inserting direction, e.g., a substantially verticaldirection relative to the patient's skin surface. Further, as shown inthe Figures, an analyte sensor 503 is provided in cooperation with theintroducer portion 502 such that in one embodiment, when the triggerportion 501 is activated by the patient, for example, by the applicationof downward pressure on the outer surface of the trigger portion (theouter surface of the “dome shaped” area), the introducer portion 502 isin turn configured to be driven in a substantially complimentarydirection to the direction of the applied pressure, and further,displacing at least a portion of the sensor 503 with the introducerportion 502. In other words, the introducer portion 502 is configured inone embodiment to transcutaneously place a portion of the sensor 503 sothat the portion of the sensor is in fluid contact with the biologicalfluid (for example, interstitial fluid) of the patient.

Referring to FIGS. 5A-5B, the sensor 503 is in one embodiment alsoprovided with one or more contact points 504 which are configured to bein electrical contact with the corresponding electrical contacts of thetransmitter unit 101. That is, in the case of analyte sensors, theworking, reference, and counter electrodes (in certain embodiments anelectrode may function as both reference and counter electrodes) areeach coupled to a respective one of the contact points 504, and in turn,each of which are in electrical communication with the respectivecontacts on the transmitter unit 101.

In this manner, in one embodiment, the sensor detected analyte levelsare provided to the transmitter unit 101, for example, as currentsignals, and which are in turn, converted to respective digital signalsfor transmission (including, for example, RF transmission) to a receiverunit for further data processing and data analysis (including drug(e.g., insulin) therapy management, infusion control, and healthmonitoring and treatment, for example). That is, the monitored analytedata may be used by the patient and/or the patient's healthcare providerto modify the patient's therapy such as an infusion protocol (such asbasal profile modifications in the case of diabetics) as necessary toimprove insulin infusion therapy for diabetics, and further, to analyzetrends in analyte levels for better treatment.

While glucose is described as an example of the detected and/ormonitored analyte, within the scope of the present invention, analytesthat may be detected or monitored also include, for example, acetylcholine, amylase, bilirubin, cholesterol, chorionic gonadotropin,creatine kinase (e.g., CK-MB), creatine, DNA, fructosamine, glucose,glutamine, growth hormones, hormones, ketones, lactate, peroxide,prostate-specific antigen, prothrombin, RNA, thyroid stimulatinghormone, and troponin. The concentration of drugs, such as, for example,antibiotics (e.g., gentamicin, vancomycin, and the like), digitoxin,digoxin, drugs of abuse, theophylline, and warfarin, may also bedetected and/or monitored.

FIG. 6 illustrates a perspective view of the sensor introducer triggermechanism and the transmitter unit base portion in cooperation with thesensor in pre-deployment position in accordance with one embodiment ofthe present invention. As shown, the one or more contact points 504 ofthe sensor 503 (which in one embodiment may correspond to a respectiveone of the working electrode, a counter electrode, and a referenceelectrode, for example), are configured to couple to a respectivecontact on the transmitter unit 101 (FIGS. 3A-3B) such that the sensor503, which is in fluid contact with the patient's biological fluids, isin electrical communication with the transmitter unit 101.

Furthermore, as can be seen from FIG. 6, the substantially dome shapedinserter introducer trigger mechanism 104 is configured to becollapsible when the patient applies downward pressure to drive theintroducer portion 502 through the patient's skin. Further, when thedownward pressure is removed from the dome shaped inserter introducertrigger mechanism 104, the outer inserter introducer trigger mechanism104 is configured to return to substantially the original shape, andconcurrent therewith, removing the introducer portion 502 from theinsertion site of the patient, while leaving behind the subcutaneousportion of the sensor in fluid contact with the patient's biologicalfluid. This can also be seen with FIGS. 7A-7B as described below.

FIG. 7A illustrates a perspective view of the sensor introducer triggermechanism and the transmitter unit base portion in post deploymentposition, and FIG. 7B illustrates a side view of the sensor introducertrigger mechanism in post sensor deployment position in accordance withone embodiment of the present invention. More specifically, it can beseen from FIGS. 7A-7B that when the downward pressure is applied uponthe substantially dome shaped inserter introducer trigger mechanism 104,the upper conical portion of the inserter introducer trigger mechanism104 takes a substantially inverted conical shape, and with the sameforce, driving the portion 701 of the sensor 503 (FIG. 5A) through thepatient's skin. In one embodiment, the inserter introducer triggermechanism 104 may be made of one of stainless steel, rubber, polyester,or PET film, or any other suitable material that is flexible andprovides the properties described herein, including being reversiblycollapsible.

FIG. 8A is a cross sectional view of the sensor introducer triggermechanism 104 before the sensor insertion, and FIG. 8B is a crosssectional side view of the sensor introducer trigger mechanism 104before the sensor insertion in accordance with one embodiment of thepresent invention. As can be seen from FIG. 8A, the portion 701 of thesensor 503 is substantially retained in cooperation with the introducerportion 502 (e.g., a microneedle), all of which are substantiallyretained within the integrated inserter introducer and transmitterassembly 100 (FIGS. 1A-1B).

Moreover, referring to FIG. 8B, the non-transcutaneously displacedportion of the sensor 503 is also substantially completely retainedwithin the integrated inserter introducer and transmitter assembly 100.That is, in one embodiment of the present invention, the transmitterunit 101 as well as the sensor insertion mechanism (e.g., sensorintroducer trigger mechanism 104) are provided within a singleintegrated housing. Furthermore, as discussed in additional detailbelow, after the deployment of the sensor 503 transcutaneously so as tohave a portion 701 thereof in fluid contact with the patient'sbiological fluid, the sensor insertion mechanism is retained within theintegrated housing itself, so that the patient is not required tofurther handle the sharp and contaminated needle portion of the sensorintroducer assembly.

FIGS. 9A and 9B are cross sectional views of the sensor introducertrigger mechanism 104 after sensor insertion and withdrawal of theintroducer for retention within the integrated sensor introducer andtransmitter assembly in accordance with one embodiment of the presentinvention. Referring to FIGS. 9A-9B, it can be seen that after thesensor 503 is placed transcutaneously through the patient's skin at theintended location and in fluid contact with the patient's biologicalfluid, the introducer portion 502 is retained substantially completelywithin the dome shaped sensor introducer trigger mechanism 104 providedwithin the integrated sensor introducer and transmitter assembly 100.

Furthermore, while the sensor 503 is described as substantiallytranscutaneously placed in the patient, within the scope of the presentinvention, the sensor may be wholly implantable under the skin of thepatient, or at least a portion of the sensor may be provided under theskin of the patient so as to be in fluid contact with the patient'sinterstitial fluid.

In one embodiment, the introducer portion 502 is configured to beretained within the assembly 100 during the entire duration of thesensor 503 in operation for monitoring the patient's analyte levels, andis discarded along with the sensor 503 after use. In this manner, whilethe transmitter unit 101 may be reusable, in one embodiment of thepresent invention, the base portion 103 and the sensor introducertrigger mechanism 104 along with the sensor 503 are discarded after eachuse.

Further, the detected analyte signals from the sensor 503 may beprovided to transmitter unit 101, which is, in one embodiment,configured to wirelessly or otherwise transmit data corresponding to thedetected analyte levels from the sensor 503 to a receiver unit, wherethe receiver unit may include an analyte, e.g., glucose, monitor unitand/or an insulin pump unit and/or a computer terminal and/or any otherelectronic device capable of being configured for wirelesscommunication. A physical connection may be provided in certainembodiments.

Within the scope of the present invention, the receiver unit functionsmay be integrated into portable electronic devices such as a watch, apager, a mobile telephone, and a personal digital assistant. Additionalinformation on the detection, monitoring and analysis of analyte levels,are described in further detail in U.S. Pat. No. 6,175,752, entitled“Analyte Monitoring Device and Methods of Us,” the disclosure of whichis incorporated herein by reference for all purposes. In certainembodiments, the transmitter may also be capable of wirelessly orotherwise receiving a signal from a receiver such that a receiver mayalso be capable of transmitting information to the transmitter.

In a further embodiment, the transmitter unit 101 may include a wirelesscommunication unit for wireless transmission of the signal, where thewireless communication unit may include one or more of a radio frequency(RF) communication unit, a Bluetooth® communication unit, an infraredcommunication unit, an 801.11x communication unit, or a Zigbeecommunication unit. Similarly, the receiver unit may be configured tosupport one or more of the above-referenced wireless communicationprotocols to communicate with the transmitter unit.

In the manner described above, an apparatus including an integratedsensor insertion unit includes a base unit, a sensor coupled to the baseunit, and an insertion unit disposed on the base unit, the insertionunit operatively coupled to the sensor and configured to place at leasta portion of the sensor under a skin of a patient, wherein the insertionunit is configured to remain disposed on the base unit after sensorplacement.

In one embodiment, a transmitter unit may be disposed on the base unit,where the transmitter unit is configured to operatively couple to thesensor. Also, the transmitter unit may include an opening portionconfigured to substantially cover the insertion unit when thetransmitter unit is disposed on the base unit, where the opening portionis slidably disposed on the transmitter unit to selectively expose theinsertion unit. Further, the opening portion may be alternatelypivotally mounted to the transmitter unit to selectively expose theinsertion unit.

Additionally the base unit, the sensor, and the insertion unit in oneembodiment may be formed as an integrated disposable unit.

In a further embodiment, the insertion unit may include a sharp portion,the sharp portion configured to couple to a portion of the sensor, thesharp portion further configured to pierce through a skin of the patientto position at least the portion of the sensor in the patient, where atleast the portion of the sensor may be configured to be in fluid contactwith a biological fluid of a patient. In one embodiment, the biologicalfluid includes one of interstitial fluid or blood.

In an additional embodiment, the sensor is an analyte sensor, whichincludes a glucose sensor.

An apparatus in still a further embodiment of the present inventionincludes a transmitter mount, a sensor coupled to the transmitter mount,the sensor configured to be in fluid contact with a biological fluid ofa patient, and a sensor introducer coupled to the sensor and configuredto place at least a portion of the sensor under the skin of the patient,the sensor introducer integrated with the transmitter mount such thatthe sensor introducer is retained with the transmitter mount aftersensor placement.

Also provided in still a further embodiment, is an adhesive layer wherethe transmitter mount disposed on the adhesive layer, and a transmitterunit coupled to the transmitter mount on the adhesive layer, where thetransmitter unit further configured to be in electrical communicationwith the sensor.

The adhesive layer in one embodiment is positioned substantially arounda sensor insertion location on the skin of the patient.

Moreover, the transmitter unit may include an opening portion, theopening portion configured to selectively provide access to the sensorintroducer.

Further, the transmitter unit in yet another embodiment may beconfigured to transmit one or more signals corresponding to a respectiveone or more sensor signals, where the one or more sensor signals maycorrespond to or are associated with a respective one or more of analytelevels detected by the sensor.

The one or more analyte levels may include one of a glucose level, alactate level, or an oxygen level.

In addition, in a further embodiment, there may be provided a receiverunit configured to receive the one or more signals from the transmitterunit.

A method in yet still another embodiment includes the steps of placingat least a portion of a sensor under the skin of a patient,substantially covering the sensor introducer mechanism, and discardingthe sensor introducer mechanism with the sensor.

An analyte detection apparatus for use with an analyte sensor in stillanother embodiment includes a transmitter, and an analyte sensorinsertion unit operatively coupled to the transmitter.

A system in accordance with still another embodiment includes atransmitter mount, a sensor coupled to the transmitter mount, the sensorconfigured to be in fluid contact with a biological fluid of a patient,a sensor introducer coupled to the sensor and configured to place atleast a portion of the sensor under the skin of the patient, the sensorintroducer integrated with the transmitter mount such that the sensorintroducer is retained with the transmitter mount after sensorplacement, and a transmitter unit coupled to the transmitter mount, thetransmitter unit electrically coupled to the sensor, and configured totransmit one or more signals associated with the biological fluid levelsof the patient.

An insertion kit in one embodiment of the present invention includes abase unit, a sensor coupled to the base unit, and an insertion unitdisposed on the base unit, the insertion unit operatively coupled to thesensor and configured to place at least a portion of the sensor under askin of a patient, the insertion unit including a sensor introducer,wherein the sensor introducer is retained substantially disposed on thebase unit after sensor placement.

Various other modifications and alterations in the structure and methodof operation of this invention will be apparent to those skilled in theart without departing from the scope and spirit of the invention.Although the invention has been described in connection with specificpreferred embodiments, it should be understood that the invention asclaimed should not be unduly limited to such specific embodiments. It isintended that the following claims define the scope of the presentinvention and that structures and methods within the scope of theseclaims and their equivalents be covered thereby.

1-20. (canceled)
 21. A method of using a sensor introducer assembly, thesensor introducer assembly comprising an insertion unit operativelycoupled to an analyte sensor, wherein the insertion unit includes acompressible introducer mechanism coupled to a sensor introducer, themethod comprising: placing a base portion of the sensor introducerassembly on a skin surface of a patient; applying a manual force on asurface of the compressible introducer mechanism to cause thecompressible introducer mechanism to move from a non-compressed state toa compressed state; inserting, by the compressible introducer mechanism,at least a portion of the analyte sensor and the sensor introducerthrough a skin layer to an insertion position under the skin layer; andautomatically withdrawing the at least the portion of the sensorintroducer from under the skin layer while retaining the at least theportion of the analyte sensor at the insertion position, wherein theinsertion unit and compressible introducer mechanism are containedwithin a housing when the compressible introducer mechanism is in thenon-compressed state and the compressed state, and wherein the sensorintroducer includes a sharp portion configured to releasably couple withthe at least the portion of the analyte sensor.
 22. The method of claim21, further comprising driving the sharp portion, by the manual force,to pierce through the skin layer and to position the at least theportion of the analyte sensor in fluid contact with a biological fluidunder the skin layer at the insertion position.
 23. The method of claim22, wherein the biological fluid includes one of interstitial fluid orblood.
 24. The method of claim 21, wherein the analyte sensor is aglucose sensor.
 25. The method of claim 21, wherein the analyte sensoris operatively coupled to sensor electronics.
 26. The method of claim25, wherein the sensor electronics include an opening portion, theopening portion configured to selectively provide access to the sensorintroducer.
 27. The method of claim 25, further comprisingcommunicating, by the sensor electronics, one or more signalscorresponding to an analyte level monitored by the analyte sensor. 28.The method of claim 27, wherein the sensor electronics further comprisea wireless communication unit configured to wirelessly transmit signalsaccording to at least one of a radio frequency (RF), a Bluetoothprotocol, an infrared protocol, an 802.11x communication protocol, and aZigbee communication protocol.
 29. The method of claim 21, furthercomprising removing the manual force from the compressible introducermechanism to cause the compressible introducer mechanism to move fromthe compressed state to the non-compressed state.
 30. The method ofclaim 21, wherein the compressible introducer mechanism includes asubstantially dome-shaped outer surface.
 31. A method, comprising:applying a manual force on a surface of a compressible introducermechanism coupled to a sensor introducer to cause the compressibleintroducer mechanism to move from a non-compressed state to a compressedstate; driving a sharp portion of the sensor introducer to piercethrough a skin layer of a patient; inserting, by the compressibleintroducer mechanism, at least a portion of the analyte sensor and atleast a portion of the sensor introducer to an insertion position underthe skin layer; and automatically withdrawing the at least the portionof the sensor introducer from under the skin layer while retaining theat least the portion of the analyte sensor at the insertion position,wherein the at least the portion of the analyte sensor is substantiallyretained within the least the portion of the sensor introducer prior toinsertion of the at least the portion of the analyte sensor and the atleast the portion of the sensor introducer through the skin layer. 32.The method of claim 31, wherein the insertion unit and the compressibleintroducer mechanism are contained within a housing when thecompressible introducer mechanism is in the non-compressed state and thecompressed state.
 33. The method of claim 31, wherein the analyte sensoris operatively coupled to sensor electronics.
 34. The method of claim33, wherein the sensor electronics include an opening portion, theopening portion configured to selectively provide access to the sensorintroducer.
 35. The method of claim 34, wherein the opening portioncomprises an aperture positioned through a relatively center portion ofthe sensor electronics.
 36. The method of claim 33, further comprisingcommunicating, by the sensor electronics, one or more signalscorresponding to an analyte level monitored by the analyte sensor. 37.The method of claim 36, wherein the sensor electronics further comprisea wireless communication unit configured to wirelessly transmit signalsaccording to at least one of a radio frequency (RF), a Bluetoothprotocol, an infrared protocol, an 802.11x communication protocol, and aZigbee communication protocol.
 38. The method of claim 31, wherein thecompressible introducer mechanism includes a substantially dome-shapedouter surface.
 39. The method of claim 31, further comprising removingthe manual force from the compressible introducer mechanism to cause thecompressible introducer mechanism to move from the compressed state tothe non-compressed state.
 40. The method of claim 31, wherein the manualforce comprises a pressure force in a direction toward the skin surfaceof the patient.